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NCT03547700 · OUTCOME

Phase I: Maximum Tolerated Dose (MTD)

Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) · Source last updated 2026-05-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
From first dose of treatment through the 1st cycle (28 days)

What was measured

MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.

Groups in this outcome

All Subjects Treated

Romidepsin dose of either 10mg/m², 14mg/m² IV on days 1, 8, 15, or 14mg/m² on days 1 and 8 : Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Subjects Treated11

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects TreatedNANot reportedNot reportedNot reportedSince the minimum number of subjects needed to evaluate MTD were not enrolled, the MTD could not be determined.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Since the minimum number of subjects needed to evaluate MTD were not enrolled, the MTD could not be determined.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled. The maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.
groups
  1. description
    Romidepsin dose of either 10mg/m², 14mg/m² IV on days 1, 8, 15, or 14mg/m² on days 1 and 8 : Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. Ixazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
    id
    OG000
    title
    All Subjects Treated
param Type
NUMBER
reporting Status
POSTED
time Frame
From first dose of treatment through the 1st cycle (28 days)
title
Phase I: Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/m^2

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice